Presentations for the September 15, 2020 Meeting of the Pediatric Advisory Committee
- Pediatric Advisory Committee Opening Remarks
Susan McCune, M.D., Director, Office of Pediatric Therapeutics - Vyvanse (lisdexamfetamine) Pediatric Focused Safety Review
Ivone Kim, M.D., CDER - Mydayis (mixed salts of single entity amphetamine) and Adzenys ER (amphetamine extended release) Pediatric Focused Safety Review Mohamed A. Mohamoud, Pharm.D., M.P.H., BCPS, CDER
- Orencia (abatacept) Pediatric Focused Safety Review
- Additional Slides: Descriptive Characteristics of Angioedema Case Series with Abatacept
- GAMUNEX-C: Hypersensitivity reactions in patients receiving certain product lots
Craig Zinderman, M.D., M.P.H., CBER - Flourish™ Pediatric Esophageal Atresia Device: H150003
Priya Venkataraman-Rao, M.D., FAAP - Flourish™ Pediatric Esophageal Atresia Device Sponsor Presentation